A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-04-27, after 2021-07-28 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-04-27. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: bmsheartdiseaseacuteinfarction
Phrases that lowered it: participantshealthykgasthmaeffect of -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 12.2% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 84 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 765 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 79.7% (lowers risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports before start: 58205 (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 765 (typical: 32)
- Sponsor's past termination rate
- 9.9%
- Trials the sponsor started in the prior 2 years
- 84 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 58205 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4046 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- gemfibrozil, itraconazole, phenytoin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants NCT05932303 · started 2023 · scored riskier than 2% of active trials completed
- A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants NCT06170723 · started 2024 · scored riskier than 4% of active trials completed
- A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects NCT02807909 · started 2016 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants NCT05852769 · started 2023 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects NCT03346837 · started 2017 · scored riskier than 2% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.